Constituent Update

November 22, 2023

The FDA has published a new resource for industry on the new requirement for manufacturers of critical foods to develop a redundancy risk management plan.

This new requirement, in section 424(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), was established through the Food and Drug Omnibus Reform Act of 2022 (FDORA) and requires manufacturers of critical foods to develop, maintain, and implement, as appropriate, redundancy risk management plans. This requirement went into effect immediately following the enactment of FDORA on December 29, 2022. To help ensure critical food manufacturers are aware of and are taking steps to implement this new requirement, the FDA is sharing a one-page resource for industry, which is now available on the agency’s infant formula landing page, and which will be provided to critical food manufacturers during routine inspections.

This new requirement was established following a months-long infant formula shortage sparked by insanitary conditions at one of the nation’s largest infant formula facilities, which led to a significant voluntary recall and multiple-month production shutdown. The shortage of a food that is the sole-source of nutrition for infants elevated the need for firms to have plans in place to deal with supply chain and manufacturing disruptions that could significantly impact the amount of infant formula (or other critical foods) available to consumers.  

The FDA remains committed to strengthening the safety and resiliency of the supply of infant formula and other critical foods in the United States.

Additional Information:

• Information for Infant Formula Manufacturers